Abstract
In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries. When they work, people live; when they fail, people die. As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda.
Highlights
Medical product regulatory systems are central to health systems; they ensure high quality and safe interventions like drugs, vaccines, and medical devices for patients who need and count on them
World Health Organization (WHO) has recognized their importance, to date, little attention has been focused on regulatory systems in lowand middle-income countries
We propose that strengthening regulatory systems in low- and middle-income countries must become a global health priority, and explain the imperative in terms of globalization and the rapid scale up of medicines to the developing world
Summary
Medical product regulatory systems are central to health systems; they ensure high quality and safe interventions like drugs, vaccines, and medical devices for patients who need and count on them. N This article explores case studies in regulatory domains such as global product supply chains, clinical trials, premarket approval, post-market surveillance, and regulatory science to demonstrate the essential value of medical product regulatory systems to low- and middle-income countries. Donors like the Global Fund to Fight AIDS, TB and Malaria (Global Fund), the GAVI Alliance, and the Bill and Melinda Gates Foundation are beginning to support post-market surveillance work, but much more needs to be done Another example of why strengthening regulatory systems in low- and middleincome countries is important to global health is in the area of regulatory science, which is the development of public sector tools, methods, and models to accelerate and improve the regulation of innovative and generic products. If regulatory science can be strengthened in low- and middle-income countries, many more successes like MenAfriVac will be possible
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